Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

Eligibility Criteria

• 1. Pathologically confirmed mycosis fungoides/sezary syndrome at the enrolling institution, disease stage IB (defined as patches, plaque, or papules that involve 10% of the skin surface viscera) or higher
• 2. Age ≥ 18 years
• 3. ECOG Performance Score ≤ 2
• 4. For Cohort 1, patients who have not received brentuximab vedotin are eligible.
• 5. For Cohort 2, patients who have previously had brentuximab vedotin for MF/SS are eligible. Patients previously treated on Cohort 1 who were discontinued due to toxicity are not eligible for Cohort 2.
• 6. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment.
• 7. Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and/or unnecessary suffering, after discussion with PI.
• 8. If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count \>200 within 7 days prior to C1D1.
• 9. Females of childbearing potential must be on acceptable form of birth control per instutional standard.
• 1. Pathologically confirmed lymphomatoid papulosis at the enrolling institution
• 2. Requiring systemic treatment per investigator's discretion
• 3. Age ≥ 18 years
• 4. ECOG Performance Score ≤ 2
• 5. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment.
• 6. Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and/or unnecessary suffering.
• 7. If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count \>200 within 7 days prior to C1D1.
• 8. Females of childbearing potential must be on acceptable form of birth control per institutional standard
• 1. Concurrent use of other systemic anti-cancer agents or treatments for mycosis fungoides/sezary syndrome, or lymphomatoid papulosis.
• 2. Grade 2 or greater neuropathy
• 3. Severe renal impairment (CrCL \<30 mL/min)
• 4. Moderate or severe hepatic impairment (Child-Pugh B or Child-Pugh C)
• 5. Women of reproductive potential† must have a negative Serum ß human chorionic gonadotropin (ß-HCG) pregnancy test within 1 week of C1D1. They should discuss contraception with treating provider.
• 6. Previous use of brentuximab vedotin (for Cohort 1 ONLY)
• 7. Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma).
• * Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.
• * Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) is permissible after discussion with the MSK Principal Investigator.
• 8. For Cohort 2, patients who previously progressed on the standard 1.8mg/kg dose and schedule of brentuximab vedotin are ineligible.
• * A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).